MONTREAL and CHARLOTTE, N.C. - Milestone Pharmaceuticals Inc . (NASDAQ:MIST), a biopharmaceutical company, announced today that its licensing partner, Ji Xing Pharmaceuticals Ltd, reported positive results from a Phase 3 trial in China for etripamil nasal spray, a treatment for paroxysmal supraventricular tachycardia (PSVT). The trial demonstrated that etripamil significantly increased the conversion of PSVT to sinus rhythm within 30 minutes compared to a placebo.
The study, involving 500 patients, met its primary endpoint. Kaplan Meier analysis showed that 40.5% of patients who self-administered etripamil converted to normal heart rhythm within 30 minutes, versus 15.9% for the placebo group. The trial also met secondary efficacy endpoints, showing significant conversion rates at various intervals post-administration. No serious adverse events related to etripamil were reported, and the safety data aligned with previous studies.
Milestone Pharmaceuticals has granted Ji Xing an exclusive license to develop and potentially commercialize etripamil in Greater China, which includes Mainland China, Hong Kong, Macau, and Taiwan. Milestone has received an upfront payment of $15 million and a $5 million equity investment, with the potential for up to $107.5 million in milestone payments plus royalties on future sales in the region.
PSVT is a condition characterized by sudden episodes of rapid heart rate, often causing severe symptoms and distress. Current treatment options are limited, often requiring emergency medical attention or invasive procedures.
Etripamil, Milestone's lead investigational product, is a self-administered calcium channel blocker nasal spray that has undergone a robust clinical trial program, including a completed Phase 3 study for PSVT and a Phase 2 trial for atrial fibrillation with rapid ventricular rate (AFib-RVR). If approved, etripamil could provide patients with a new on-demand treatment option, potentially reducing the need for emergency care.
The information in this article is based on a press release statement from Milestone Pharmaceuticals Inc.
In other recent news, Milestone Pharmaceuticals has made significant changes to its Board of Directors. The biopharmaceutical company announced the immediate appointment of Stuart Duty and Andrew Saik as independent directors, as part of a board refreshment strategy. Duty, a seasoned investment banker, and Saik, an expert in accounting and finance, are expected to bring valuable insights to Milestone's growth strategies. The company also revealed a Cooperation Agreement with Alta Fundamental Advisers LLC, one of its shareholders.
In addition to these board changes, H.C. Wainwright has reaffirmed its Buy rating on Milestone Pharmaceuticals, maintaining a positive outlook on the company's expansion potential. The endorsement follows a recent educational event hosted by Milestone, where the therapeutic candidate, CARDAMYST (etripamil) nasal spray, was highlighted. H.C. Wainwright believes the market dynamics of paroxysmal supraventricular tachycardia (PSVT), the condition CARDAMYST is designed to treat, are conducive to the early success and substantial growth potential of the product.
These developments underscore the recent changes and future potential within Milestone Pharmaceuticals, as the company continues to evolve and make strides in the biopharmaceutical field.
InvestingPro Insights
Milestone Pharmaceuticals Inc. (NASDAQ:MIST) has recently shared promising clinical trial results for its etripamil nasal spray, which could revolutionize the treatment for PSVT by providing a self-administered option. As investors consider the potential of Milestone's pipeline, current financial health and market performance are critical factors to evaluate.
InvestingPro data indicates that Milestone Pharmaceuticals holds a market capitalization of $96.62 million. Despite the positive clinical trial outcomes, the company's financials reflect some challenges. It has a negative P/E ratio, last reported at -1.5, suggesting that the company is not currently profitable. Additionally, the company's operating income, adjusted for the last twelve months as of Q2 2024, stands at a loss of $49.3 million. This aligns with an InvestingPro Tip highlighting that analysts do not anticipate Milestone will be profitable this year.
However, it's not all bleak for the company's financial standing. Milestone carries more cash than debt on its balance sheet, which is a positive sign of liquidity and financial stability. Another InvestingPro Tip worth noting is that the company's liquid assets exceed its short-term obligations, providing some cushion for its cash burn. This is particularly important as the company continues to invest in its product pipeline.
For those interested in Milestone's stock volatility, it's worth noting that the stock price has experienced significant fluctuations. Over the past year, the price has seen a decline of 51.33%. Despite this, there has been a recent uptick with a 1-month price total return of 8.96%. For investors looking to make informed decisions, additional InvestingPro Tips are available, with a total of 8 tips listed on the platform.
The journey of Milestone Pharmaceuticals as it moves towards potential commercialization of etripamil in Greater China is one to watch. With the InvestingPro product, investors can stay updated on the latest metrics and expert analysis to better navigate the biopharmaceutical landscape.
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